Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01444690
Other study ID # NT-004-DIPANAP
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received September 29, 2011
Last updated September 30, 2011
Start date January 2012
Est. completion date January 2013

Study information

Verified date September 2011
Source Neurotune AG
Contact Rugerro Fariello, MD
Phone +41-91-6056542
Email ruggero.fariello@neurotune.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and tolerability of orally administered dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents presenting a disease and /or treatment related neuropathic pain.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 244
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- male and female patients aged 18-75 years inclusive;

- females of child-bearing potential only if agreeing prior to screening to use a medically accepted method of contraception, i.e., oral or injectable hormonal contraceptive with a second method of birth control, medically prescribed intrauterine device (IUD), or double barrier method (condom in combination with spermicidal). Females, who are not currently sexually active, only if agreeing and consenting to use one of the above-mentioned methods in case they become sexually active while participating in the study;

- females of not child-bearing potential only if permanently sterilised or if in post-menopausal status, only if they have been in this status for at least 2 years; females of not child-bearing potential are exempted from the requirement for use of contraception;

- HIV-positive patients treated with ARTs;

- CD4+ cell count > 200/µL at the screening;

- patients affected by current neuropathic pain likely to be ART treatment related. The diagnosis shall be made by a physician and based on history, clinical and/or laboratory findings in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain;

- naïve neuropathic patients or non-responders (residual pain =40 mm on the VAS) to standard neuropathy treatments. Drugs for neuropathic pain (NP) must be stopped at screening visit;

- pain intensity =40 mm on the VAS at screening;

- pain intensity =40 mm on the VAS as the mean of the values collected on the last 4 days prior to the start of treatment (baseline VAS);

- life expectancy of at least 6 months;

- ability to comprehend the full nature and purpose of the study, including possible risks and side effects;

- ability to co-operate with the Investigator or designee and to comply with the requirements of the entire study

Exclusion Criteria:

- pregnant or lactating females;

- presence of active AIDS-defining opportunistic infections (with the exception of tuberculosis) or malignant neoplasia requiring treatment at study entry or Kaposi's sarcoma or another malignant neoplasia likely to require chemotherapy;

- any clinically significant underlying disease, according to the Investigator's clinical judgment;

- history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment);

- any current DSM-IV Axis I diagnosis including dementia, depression, psychosis, anxiety disorders, mental retardation;

- participation in the evaluation of any investigational drug within 3 months prior to screening (6 months if for treatment of neuropathic pain)

- treatment with neurostimulating devices such as spinal cord stimulation (SCS), acupuncture, homeopathic remedies for pain or any kind of surgical treatment or blockade for the pain in the 4 weeks prior to screening;

- treatment with any drug for neuropathic pain (NP) after the screening visit;

- requirement of more than 2 transfusions / month to achieve haemoglobin level > 8 g/dL;

- history of alcohol abuse (no more than 4 drinks in a day and 14 drinks in a week for men or 3 drinks per day and 7 drinks in a week for women as defined according to both NIAAA and USDA dietary guidelines) or drug abuse during the last 3 mo prior to screening;

- Less than 1 VAS assessment per day for each of the last 4 days.

- history of allergic response to neuropathic treatments or history of anaphylaxis or allergic reactions to drugs in general;

- any abnormality that the Investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in diagnostic laboratory test;

- subjects likely to be non-compliant or uncooperative during the study according to the Investigator or designee's judgement

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dimiracetam
Capsules for oral administration twice daily
Dimiracetam 25 mg
Inactive dose level in capsules administered orally twice daily

Locations

Country Name City State
Switzerland Neurotune AG Lugano

Sponsors (1)

Lead Sponsor Collaborator
Neurotune AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity measured on 100 mm VAS Change from baseline in pain intensity as measured on VAS 71 days No
Primary Pain intensity as measured with Total Symptom Score (TSS) Change from baseline as measured with TSS 71 days No
Secondary Adverse events Comparison of AE frequency between treatment groups 78 days Yes
Secondary Number needed to treat NNT needed to obtain a >60% pain relief from the initial score recorded on the VAS and TSS at study entry 71 days No
Secondary CD4+ cell count comparison of CD4+ cell count vs. baseline within and between treatment groups 78 days Yes
Secondary HIV viral load comparison of HIV viral load vs. screening within and between treatment groups 78 days Yes
See also
  Status Clinical Trial Phase
Completed NCT01968551 - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults Phase 3
Completed NCT02929069 - A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk N/A
Recruiting NCT02392884 - HIV Medication Adherence in Underserved Populations N/A
Completed NCT02264509 - Peripheral Arterial Insufficiency Associated With HIV/AIDS N/A
Completed NCT02583464 - Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Phase 1
Completed NCT01440569 - Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults Phase 3
Completed NCT00551330 - Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED) Phase 2
Completed NCT00381212 - A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent. Phase 1/Phase 2
Completed NCT00097006 - Retrovirus Epidemiology Donor Study-II (REDS-II) N/A
Completed NCT00001409 - Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications Phase 1
Completed NCT00000590 - Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185) Phase 3
Completed NCT00000587 - Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection Phase 2
Completed NCT00005273 - Pulmonary Complications of HIV Infection Study (PACS) N/A
Completed NCT00005303 - Effectiveness of AIDS Antibody Screening N/A
Completed NCT00005301 - Transfusion Safety Study (TSS) N/A
Completed NCT00001650 - Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients N/A
Withdrawn NCT00243568 - Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285 Phase 3
Recruiting NCT05031819 - Managing Hypertension Among People Living With HIV N/A
Completed NCT00394004 - Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials N/A
Completed NCT01967940 - Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults Phase 3